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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00517413 |
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Date of registration:
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16/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
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Scientific title:
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A Single-Arm Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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163 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00517413 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Brazil
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Chile
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Colombia
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Ecuador
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Mexico
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Nicaragua
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Peru
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Uruguay
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Venezuela
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before
and throughout screening period;
- stable maintenance epoetin alfa therapy for past 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in past 6
months;
- acute or chronic bleeding during previous 2 months.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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Primary Outcome(s)
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Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
[Time Frame: EEP (Week 16 to 24)]
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Secondary Outcome(s)
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Mean C-Reactive Protein Levels Over Time
[Time Frame: Baseline (Week 0), 8, 16, 24, 32, 40, and 48]
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Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP
[Time Frame: SVP (Week -4 to -1), EEP (Week 16 to 24)]
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Mean Ferritin Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP
[Time Frame: EEP (Week 16 to 24)]
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Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP
[Time Frame: EEP (Week 16 to 24)]
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Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
[Time Frame: Baseline (Week 0) to Week 44]
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Mean Hematocrit Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48]
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Mean White Blood Cells and Thrombocyte Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Mean Albumin and Transferrin Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Mean Haemoglobin Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48]
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Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Mean Monthly Dose of C.E.R.A During the DTP and EEP
[Time Frame: Baseline (Week 0) to Week 24]
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Mean Phosphate and Potassium Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP
[Time Frame: Baseline (Week 0) to Week 24]
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Number of Participants With Adverse Events and Serious Adverse Events
[Time Frame: Up to Week 52]
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Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP
[Time Frame: EEP (Week 16 to 24)]
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Mean Transferrin Saturation Levels Over Time
[Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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